Sodium Cromoglycate
Indications
Registered South African indications:
- Allergic conjunctivitis
Cautions
Contraindications
South African recommendations & Recommendations in other jurisdictions
- Hypersensitivity to sodium cromoglycate, benzalkonium chloride or to any of the excipients
Cautions
- Pregnancy
- Breastfeeding
- Concomitant use of soft contact lenses
- Extensive ocular surface disease
Adult dosage
Forms avail. in SA and covered in this monograph: opd
Dosages below include:
- South African registered indications and dosages
South African registered indications and dosages
Prevention and treatment of allergic conjunctivitis
- Ophthalmic (opd): 1-2 drops into each eye(s), 4 times daily
It is important that the regular administration of sodium cromoglycate is maintained in the prevention and treatment of allergic conjunctivitis as therapy is essentially prophylactic
The solution should be discarded 1 month after first opening the bottle or if any turbidity develops
Patients should also be instructed that ocular solutions, if handled improperly can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. Patients should also be advised that if they develop any intercurrent ocular condition (e.g. trauma, ocular surgery or infection), they should immediately seek their medical practitioner’s advice concerning the continued use of sodium cromoglycate. There have been reports of baterial keratitis associated with the use of topical ophthalmic products
Paediatric dosage
See adult dosage
Special populations
Pregnancy
- Caution
- Cromoglicic acid should be used cautiously during pregnancy. The widespread use of sodium cromoglycate has yet to reveal any adverse effects to mother or child during pregnancy
Breastfeeding
- Caution
- It is not known whether sodium cromoglycate is excreted in human breast milk but on the basis of its physicochemical properties, this is considered unlikely. There is no information to suggest that the use of sodium cromoglycate has any undesirable effects on the baby
Renal Impairment
Hepatic Impairment
Elderly
Porphyria Information
Drugs in Sport
- Permitted - No warnings
Adverse reactions
Immune, Blood and Lymphatic System Disorders
- Hypersensitivity reactions
Sensory Disorders
- Transient stinging and burning
- Local irritation
Interactions
No information available
Monitoring
None routine. Specific cases may require
- Ophthalmic examination
Mechanism of action
Cromoglicic acid inhibits the release of allergy mediators by stabilising the membranes of sensitised mast cells.
Dosage forms
- Eye drops
Formulation
Eye drops (per ml) 20mg
- Bausch & Lomb Vividrin Eye Drops (Soflens) originator
- Stop-Allerg Eye Drops (Genop)
- Cromohexal Eye Drops (Sandoz)
Also available in the following form: Nasal spray.
References
1. SAMF_12th Edition_Page 582 2. SmPC: Vividrin eye Drops 2%, Bausch & Lomb: Last updated on eMC: 20 Sep 2007; Downloaded online 19 Nov 2018 [https://drive.google.com/drive/u/0/folders/1f5LL9cR3RZIiFcqbP8n_NKfQxDg8ce_T] 3. PI: Vividrin Eye Drops, iNova Pharmaceuticals (Pty) Ltd:Date of registration: 08 May 1989 [https://drive.google.com/drive/u/0/folders/1f5LL9cR3RZIiFcqbP8n_NKfQxDg8ce_T] 4. Drugs.com: Cromolyn ophthalmic; Downloaded online 19 Nov 2018 [https://drive.google.com/drive/u/0/folders/1f5LL9cR3RZIiFcqbP8n_NKfQxDg8ce_T] 5. U2D: Cromolyn (sodium cromoglicate) (ophthalmic): Drug information; Uptodate; Downloaded online; 28 Nov 2018 https://www.uptodate.com/contents/cromolyn-sodium-cromoglicate-ophthalmic-drug-information? source=search_result&search=cromoglycic%20acid&selectedTitle=1~58 6. NAPOS The Drug Database for Acute Porphyria: Cromoglicic acid; Accessed online; 28 Nov 2018 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?atc_code=S01GX01&l=gbr] 7. South African Institute for Drug-Free Sport: Stop- Allergy; Accessed online; 28 Nov 2018 [http://www.drugfreesport.org.za/online-medication-check/] 8. PI - CROMOBEX_OPD - iPharma - Date of revision of text - 14 April 2023 - Downloaded online 08 June 2023 [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2023/05/CROMOBEX_PI0001v1_14-04-2023SmPC-SAHPRA_Repository.pdf] 9. SmPC - Opticrom Allergy 2% w_v Eye Drops, Solution (Aspire MAH) - Summary of Product Characteristics Updated 09-Aug-2022 - SANOFI Consumer Healthcare - Downloaded online 08 June 2023 [https://www.medicines.org.uk/emc/product/9318/smpc] 10. SmPC - Catacrom Sodium Cromoglicate 2% Preservative Free Unit Dose Eye Drops Summary of Product Characteristics Updated 22-Sep-2022 | Rayner Pharmaceuticals Limited Downloaded online 09 June 2023 [https://www.medicines.org.uk/emc/product/560/smpc]
Brands & products
4 products · stale NAPPI snapshot · refreshed 5/28/2026 · 159 days olddropsGeneric· 4 products
from R6.65/unit| Product | Strength | Pack | Sched | SEP | Unit | Disp fee | NAPPI |
|---|---|---|---|---|---|---|---|
| Stop allerg 13.5ml | 20 mg/ml | 13 | S2 | R86.49 | R6.65 | R41.81 | 894605003 |
| Vividrin eye drops | 20 mg/ml | 1 | S2 | R119.30 | R119.30 | R53.16 | 804630003 |
| Cromohexal 10ml | 10 ml | 1 | S1 | R128.88 | R128.88 | R56.47 | 822698005 |
| Cromabak 2% Eye Drops | 20 mg/ml | 1 | S2 | R155.06 | R155.06 | R65.53 | 700864001 |
- Bausch & Lomb Vividrin Eye Drops
- Cromohexal Eye Drops
- Stop-Allergy
Medical aid coverage
data not yet integrated- Comprehensive Series—
- Executive Plan—
- KeyCare Series—
- Priority Series—
- Saver Series—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.